Safety System Specialist

UCB Raleigh , NC 27611

Posted 3 weeks ago

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

Job Summary

  • The Safety Systems Specialist is part of the Safety Systems Operations team that meets the evolving Pharmacovigilance needs of UCB Patient Safety.

  • The Safety system Operations team maintains the PV systems. In this role, the individual will provide expertise in managing the ARGUS global safety system (PULSE), patient safety literature screening and safety agreement management activities, in compliance with regulations worldwide.

  • Safety Systems Specialist will oversee vendor to ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner.

  • Additionally, this function supports the development/optimization of functionalities and processes for Patient Safety operational activities related to new functionalities, interfaces or upgrade projects.

  • This individual should be a self-starter with excellent pharmacovigilance knowledge and project management capabilities in pharmacovigilance who is seeking to be part of an innovative and fast-paced team to support the company's drug development activities.

Major Accountabilities

  • Supporting the maintenance of current PULSE (Safety database), SLIM (Safety literature database), CESAM (Safety agreements database) through creating change requests, verifying business functionality and tracking complex change requests, including updates to reporting rules, product lists and code lists. Supporting minor/major upgrade projects and ensuring that changes made to the databases are controlled through change control process.

  • Working with local safety affiliates of patient safety to understand and implement local PV requirements in the global safety system.

  • Perform periodic review of configuration data and support during audits and inspections. Address audit and inspection findings and related CAPA's.

  • Other responsibilities may include lead / participation in initiatives / projects related to drug safety from the business side (working with IT functions) from inception to delivery, monitoring of compliance, providing clarifications to vendor on incidents, assignment of support request tickets to vendor.

  • Monitor and review documentation- ensure SOPs, associated instructions and other aids exist and are updated.

  • Able to use BusinessObjects reporting tool to review configurations and reporting environment functionality towards supporting various teams.

Education, Qualifications, and Competencies

  • Supporting the maintenance of current PULSE (Safety database), SLIM (Safety literature database), CESAM (Safety agreements database) through creating change requests, verifying business functionality and tracking complex change requests, including updates to reporting rules, product lists and code lists. Supporting minor/major upgrade projects and ensuring that changes made to the databases are controlled through change control process.

  • Working with local safety affiliates of patient safety to understand and implement local PV requirements in the global safety system.

  • Perform periodic review of configuration data and support during audits and inspections. Address audit and inspection findings and related CAPA's.

  • Other responsibilities may include lead / participation in initiatives / projects related to drug safety from the business side (working with IT functions) from inception to delivery, monitoring of compliance, providing clarifications to vendor on incidents, assignment of support request tickets to vendor.

  • Monitor and review documentation- ensure SOPs, associated instructions and other aids exist and are updated.

  • Able to use BusinessObjects reporting tool to review configurations and reporting environment functionality towards supporting various teams.

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